As ever more of us have apps on our smart phones that claim to support our health and well-being, one of the most common questions our digital health team are asked is, when does an App become a medical device? Followed by, and what do I have to do if it is a medical device?
If you are involved in the development of an app, whether it is stand alone or part of a basket of products helping your consumers live a healthier life, you need to be aware of the potential regulatory requirements associated with placing your product on the market in the UK.
Understanding what might make an app a medical device can make a crucial difference to how you develop your software including the development processes and quality management systems you will need to have in place.
Apps that meet the definition of a medical device need a UKCA (UK Conformity Assessed) mark, or a CE mark (although in Great Britain this is only permitted until 30 June 2023)
Medical devices without the necessary marking may be reported to the MHRA (Medicines and Healthcare products Regulatory Agency) whose investigation and enforcement powers can result in market disruption, product recalls and adverse publicity.
The importance of 'intended purpose'
The characterisation of a software app as a 'medical device' or 'non-medical device' is determined according to the 'intended purpose' of the app as defined by the developer or manufacturer.
'Intended purpose' means the use for which the app is intended according to the information supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation.
One of the key characteristics of a medical device app is to have an intended 'medical purpose'. The medical purpose determines the intended use of the app and it is the manufacturer's responsibility for defining it.
Apps with a clearly therapeutic or diagnostic – medical – intended purpose, for example that of reading values off other medical devices, warning of interactions between medicines or identifying their dosage, can clearly be classified as 'medical devices'. An example would be My Dose Coach™ an app designed for adult patients who have type 2 diabetes and who have been prescribed and are taking a once-daily long-acting basal insulin by their healthcare provider, it is a tool which calculates a dose change.
By contrast, apps without an intended medical purpose, for example apps, which merely reproduce the contents of specialist literature word for word, are 'non-medical devices'. In addition, there are apps which are difficult to classify: it has to be decided from case to case whether or not apps which provide assistance in everyday life and definitely do have a medical connection (for example by reminding the patient to take his or her medication or providing assistance in the documentation of blood parameters or BMI calculations) are 'medical devices'.
Regulation, Regulation, Regulation
There are three key regulatory steps, which may assist in identifying whether or not an app is a medical device, and if the app is a medical device which regulations may apply:
It's necessary to determine whether the app falls within the general scope of the Medical Device Regulations, as Medical Device Software (“MDSW”), as an accessory to a medical device, or as software driving or influencing the use of a (hardware) medical device.
In a typically long sentence, the UK Medical Devices Regulations 2002 define a 'Medical Device' to include;
'any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, together with any accessories, including the software intended by its manufacturer to be used specifically for diagnosis or therapeutic purposes or both and necessary for its proper application which is intended by the manufacturer to be used for the purpose of diagnosing, preventing, monitoring, treating alleviating disease, injury or handicap, modifying a the anatomy or a physiological process, or controlling conception; and does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, even if it is assisted in its function by such means'.
Questions to explore include, - Does the software claim to have a medical purpose? Does it replace a human in the examination of a specimen? Is the app a clinical calculator and of what complexity?
For example, calculation of BMI would not be a medical device but calculators of cardiovascular disease risk scores are much more likely to be medical
If the app does fall under the definition of a medical device then is it a medical device or an in-vitro medical device? Part II and Part IV of the UK MDR 2002 provide the relevant definitions. Depending on precisely how the app interacts with or is linked to physiological tests e.g. blood or saliva samples an app might be an in-vitro diagnostic medical device.
For apps placed on the market in Northern Ireland and the EU, the app will classified as a medical device if it provides information as listed in Article 2(1) of the Medical Device Regulation 2017/7451 (“MDR") and an in-vitro medical device if it provides information as listed in in Art. 2(2) of the Vitro Diagnostics Regulation 2017/7462 (“IVDR").
Once it has been determined that the app qualifies as a medical device or in-vitro diagnostic medical device (or as an accessory or component thereof), the device regulatory classification exercise can begin. Classification depends among other things on the damage that its failure or malfunction can cause to the user. Determining the risk class of a medical device is essential in specifying the steps required for CE/UKCA marking, especially in terms of the choice of conformity assessment procedure and clinical requirements.
In the UK, medical devices are classified into the following classes: I, IIa, IIb, and III, with Class I being deemed the lowest risk whereas Class II is of medium risk and Class III are deemed high-risk devices.
EU legislation also separates medical devices into four classes based on medical device types: class I, class IIa, class IIb, and class III, however, there is a new class of high-risk software that has been introduced with the MDR. Importantly, this includes stand-alone software (software that can work offline, or is a portable application).
Bringing a health related app to the market can be complicated but understanding how it might be classified and therefore the way in which you may want to gather evidence and seek accreditation, together with the registration and notifications processes is crucial.
The regulatory obligations may seem onerous but they are not optional if your app meets the definitions which in part are influenced by the claims you make for your product. It is essential to make sure your whole team understands how your product can lawfully be advertised if you are clear you do not want to be manufacturing a medical device.
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